FDAnews Announces -- FDA Device Inspections: Best Practices, New Guidance on 483 Feedback Webinar, May 15, 2019

Wednesday, May 1, 2019 General News
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Facing an upcoming device inspection? Find out what's new in dealing with the next FDA inspector.

FALLS CHURCH, Va., May 1, 2019 /PRNewswire-PRWeb/ -- FDA Device Inspections Best Practices, New Guidance on 483 Feedback

An FDAnews Webinar Wednesday, May 15, 2019, 1:30 p.m. - 3:00 p.m. EDT https://www.fdanews.com/fdadeviceinspections

A medical device inspection goes awry and one faces a Form 483. But suppose it could've been headed off before the inspector ever knocked?

Following state-of-the-art best practices would have helped — a lot. It's time to discover what's new in dealing with FDA inspectors, what they may and may not look into and what goes into the decision to issue a Form 483.

Join Washington-based FDA legal expert Rachael Hunt Esq. for 90 fast-paced minutes discovering the latest in best inspection practices. Plus, a timely look at new draft guidance on requesting FDA advice on remedying Form 483 findings. Here's what she'll cover:

  •     Interacting with inspectors: What to do when snags arise
  •     The CDRH ombudsman: When and how to use
  •     Forms 483: How to respond, fallout from an inadequate response
  •     Soliciting nonbinding 483 feedback: Impact of a new draft guidance

Remedial actions siphon away time, staff, money and resources from more important work. Why risk them when they might have been averted?

Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details: FDA Device Inspections Best Practices, New Guidance on 483 Feedback An FDAnews Webinar Wednesday, May 15, 2019, 1:30 p.m. - 3:00 p.m. EDT https://www.fdanews.com/fdadeviceinspections

Tuition: $287 per site

Easy Ways to Register: Online: https://www.fdanews.com/fdadeviceinspections By phone: 888-838-5578 or 703-538-7600

About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

SOURCE FDAnews



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